Delivery system for a self-expanding medical device

ABSTRACT

A delivery system is provided for self-expanding medical devices, such as stents. The delivery system has a restraining sheath that maintains the stent in a compressed state prior to deployment. The restraining sheath terminates distally from the deployment handle, and a wire connects the restraining sheath to the deployment handle. The restraining sheath is withdrawn from the stent to deploy the stent by pulling the wires proximally at the deployment handle.

This application claims priority to U.S. Non-Provisional Application No.14/209,097, filed Mar. 13, 2014, and U.S. Provisional Application No.61/789,885, filed Mar. 15, 2013, which are hereby incorporated byreference herein.

BACKGROUND

The present invention relates generally to medical devices and moreparticularly to delivery systems for medical devices.

Intraluminal medical devices are used by physicians to treat numerousconditions using minimally invasive procedures. Examples of intraluminalmedical devices include stents, stent-grafts, filters, valves, etc. Onetype of intraluminal medical device that has become especially common isself-expanding stents. Typically, self-expanding medical devices,including stents, are made from an elastic structure that may becompressed into a low profile state that can be passed through vesselsin a patient with minimal trauma. Once at the desired treatment site,the self-expanding medical device is released and self-expands like aspring until it contacts a tissue wall which prevents further expansion.Common materials that are used in self-expanding medical devices includenitinol and stainless steel, although other materials are also possible.

Self-expanding stents are used to treat various organs, such as thevascular system, colon, biliary tract, urinary tract, esophagus, tracheaand the like. For example, stents are commonly used to treat blockages,occlusions, narrowing ailments and other similar problems that restrictflow through a passageway. One area where stents are commonly used fortreatment involves implanting an endovascular stent into the vascularsystem in order to improve or maintain blood flow through narrowedarteries. However, stents are also used in other treatments as well,such as the treatment of aneurysms. Stents have been shown to be usefulin treating various vessels throughout the vascular system, includingboth coronary vessels and peripheral vessels (e.g., carotid, brachial,renal, iliac and femoral). In addition, stents have been used in otherbody vessels as well, such as the digestive tract.

One type of delivery system for intraluminal medical devices includes aninner catheter and an outer sheath attached to a handle arrangement. Oneportion of the handle is typically connected to the inner catheter andanother portion of the handle is typically connected to the outersheath. The inner catheter extends coaxially through the outer sheath,and the two portions of the handle are arranged to longitudinally pullthe outer sheath relative to the inner catheter. Thus, when the distalend of the delivery system is positioned within the patient's body atthe intended treatment site, the physician actuates the handle outsidethe patient's body by moving the two portions relative to each other sothat the outer sheath is withdrawn over the medical device and innercatheter. In the case of self-expanding medical devices, like stents,the outer sheath also serves to radially restrain the device in thecompressed state until the outer sheath is withdrawn. As the outersheath is withdrawn, the medical device is released in the body at thetreatment site, and in the case of a self-expanding stent, the stentexpands outward away from the inner catheter and presses against thevessel wall. Although the outer sheath is usually withdrawn by pullingthe outer sheath proximally relative to the inner catheter, it may alsobe possible to withdraw the outer sheath by pushing the inner catheterdistally relative to the outer sheath. After the medical device has beenfully released from the delivery system, the handle may then be pulledby the physician to withdraw the inner catheter and outer sheath fromthe patient's body, while leaving the medical device implanted in thebody.

Precise placement of intraluminal medical devices is a concern in mostmedical procedures. One problem that can contribute to impreciseplacement of intraluminal medical devices is deflection of the deliverysystem during deployment. This can be a particular problem in thedeployment of self-expanding medical devices, like stents, because themedical device presses outward against the inner surface of the outersheath prior to deployment. When the outer sheath is withdrawn, theoutward pressure exerted by the medical device creates friction betweenthe medical device and the outer sheath. Since the medical device istypically prevented from moving proximally with the outer sheath by astop attached to the inner catheter, the frictional force between themedical device and the outer sheath causes the outer sheath to be intension and the inner catheter to be in compression. This can cause theouter sheath to stretch in length due to the tensile force. In addition,the force required to withdraw the outer sheath can be especially high.As a result, it can be difficult for a physician to accurately controldeployment of the medical device.

Accordingly, the inventors believe it would be desirable to provide animproved delivery system for intraluminal medical devices.

SUMMARY

A delivery system is described for self-expanding medical devices. Thedelivery system has an inner catheter with a stop surface that extendsfrom the proximal end of the medical device to a deployment handle. Arestraining sheath surrounds the medical device and prevents the medicaldevice from expanding prior to deployment. The proximal end of therestraining sheath terminates distally from the deployment handle. Awire is adhered to the restraining sheath and extends from therestraining sheath to the deployment handle. The medical device isdeployed by pulling on the wire which causes the restraining sheath towithdraw proximally from the medical device. The inventions herein mayalso include any other aspect described below in the writtendescription, the claims, or in the attached drawings and any combinationthereof.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

The invention may be more fully understood by reading the followingdescription in conjunction with the drawings, in which:

FIG. 1 is a cross-sectional view of a delivery system;

FIG. 2 is a cross-sectional view of a portion of a restraining sheath;

FIG. 3 is a side view of a wire;

FIG. 4 is a cross-sectional view of a portion of another restrainingsheath;

FIG. 5 is a side view of another wire;

FIG. 6 is a cross-sectional view of a portion of another restrainingsheath;

FIG. 7 is a side view of wires with interleaved coiled portions andcoiled wires;

FIG. 8 is a cross-sectional view of a covering sheath;

FIG. 9 is a perspective view of another delivery system, showing acovering sheath;

FIG. 10 is a perspective view of the delivery system, showing arestraining sheath, wires, a spacer tube and an inner catheter;

FIG. 11 is an enlarged perspective view of area A from FIG. 9, showing ajoint between the spacer tube and the inner catheter;

FIG. 12 is a perspective view of the delivery system, showing therestraining sheath withdrawn;

FIG. 13 is an enlarged perspective view of area B from FIG. 11, showingthe wires extending from the proximal end of the inner catheter;

FIG. 14 is a perspective view of the spacer tube and the inner catheter;

FIG. 15 is a perspective view of the inner catheter;

FIG. 16 is an enlarged perspective view of area C from FIG. 14;

FIG. 17 is a perspective view of the restraining sheath and the wires;

FIG. 18 is a perspective view of the distal end of the spacer tube;

FIG. 19 is a perspective view of the proximal end of the spacer tube;

FIG. 20 is a cross-sectional view of another delivery system;

FIG. 21 is a perspective view of the delivery system;

FIG. 22 is a perspective view of a portion of the delivery system,showing the inner catheter and the wires extending through openpassageways; and

FIG. 23 is a cross-sectional view of the delivery system.

DETAILED DESCRIPTION

Referring now to the figures, and particularly to FIG. 1, a deliverysystem 10 for a self-expanding medical device 12 is shown. As shown inFIG. 1, the delivery system 10 includes a deployment handle 14 withfirst and second handle members 16, 18. The first handle member 16 isattached to a wire 20 connected to a restraining sheath 22, and thesecond handle member 18 is attached to an inner catheter 24. Preferably,a covering sheath 26 is also attached to the second handle member 18.The deployment handle 14 may also have a guide section 28 to controlproximal movement of the first handle member 16 and a proximal stop 30to limit proximal travel of the first handle member 16. However, itshould be understood that the delivery system 10 may be used withnumerous types of deployment handles including deployment handles thatwind up the wire 20 during deployment. Although it may be possible todesign the delivery system 10 as a rapid-exchange system, the deliverysystem 10 is preferably an over-the-wire system where the guide wirelumen 37 extends from the distal end of the inner catheter 24 to thedeployment handle 14. The deployment handle 14 is also preferablyprovided with a flushing port 34 that is in communication with theannular space between the covering sheath 26 and the inner catheter 24and between the restraining sheath 22 and the inner catheter 24.Although various types of medical devices 12 may be used in the deliverysystem 10, a self-expanding stent 12 made from nitinol is one preferredtype of medical device 12 that may be used.

As shown in FIG. 1, the restraining sheath 22 may have a first portion36 that extends along the length of the stent 12 and a second portion 38that extends proximally from the proximal end of the stent 12. The firstportion 36 is sized to circumferentially restrain the stent 12 in acompressed state and prevent the stent 12 from expanding until therestraining sheath 22 is withdrawn from the stent 12 by pulling thewires 20. Preferably, the second portion 38 is no longer than about 2times the length of the stent 12. As shown in FIG. 1, the second portion38 of the restraining sheath 22 may have a smaller outer profilecompared to the first portion 36. Where the second portion 38 is smallerthan the first portion 36, the second portion 38 is preferably at leastas long as the stent 12 so that the second portion 38 has enough lengthto slide through the covering sheath 26 without the first portion 36sliding into the covering sheath 26 during deployment. Alternatively,the entire length of the restraining sheath 22 may have a generallyconstant profile. The restraining sheath 22 may also terminate near theproximal end of the stent 12 if desired.

The covering sheath 26 is preferably fixed to the deployment handle 14and does not move during deployment of the stent 12. The covering sheath26 may be desirable to contain the wires 20 and provide an annular lumento direct flushing fluid from the flushing port 34 through the deliverysystem 10. The covering sheath 26 may also provide additional robustnessto the delivery system 10. Preferably, the distal end of the coveringsheath 26 extends over at least the proximal end of the restrainingsheath 22. However, it is preferred that the covering sheath 26 notextend over the portion of the restraining sheath 22 that encompassesthe stent 12. That is, the distal end of the covering sheath 26preferably extends over only the portion of the restraining sheath 22that extends proximally from the proximal end of the stent 12. Thedistal end of the covering sheath 26 may be provided with an atraumatictapered end 40 that provides a smooth transition between the restrainingsheath 22 and the covering sheath 26. The distal end of the coveringsheath 26 may also be provided with an inner diameter that fits closelyonto the outer diameter of the restraining sheath 22 to present a smoothtransition and to minimize leakage of flushing fluid between therestraining sheath 22 and the covering sheath 26.

The inner catheter 24 has a stop surface 42 that abuts the proximal endof the stent 12 during deployment to prevent the stent 12 from movingproximally during deployment. The stop surface 42 may be a metal orpolymer ring bonded to the inner catheter 24 or may be an integral stepon the inner catheter 24. As shown in FIG. 1, the proximal end of therestraining sheath 22 terminates distally from the deployment handle 14so that the deployment handle 14 and the restraining sheath 22 areseparated by a longitudinal space 44. The longitudinal space 44 must beat least as long as the longest stent 12 used in the delivery system 10to allow enough travel to withdraw the restraining sheath 22 from thestent 12. One or more wires 20 are attached to the restraining sheath 22that extend across the space 44 between the restraining sheath 22 andthe deployment handle 14. Preferably, multiple wires 20 are used thatare equally spaced circumferentially around the inner catheter 24. Theproximal end of the wires 20 may be attached to the first handle member16 or any type of mechanism designed to pull the wires 20. Thus, thestent 12 may be deployed by pulling on the wires 20 to proximallywithdraw the restraining sheath 22 away from the stent 12. Since thestop surface 42 prevents the stent 12 from moving proximally with therestraining sheath 22, the restraining sheath 22 uncovers the stent 12as it moves proximally. As a result, the stent 12 is allowed toself-expand toward a vessel wall and radially away from the innercatheter 24.

As shown in FIGS. 2-3, the wire 20 may have a coiled portion 46 and astraight portion 48. The coiled portion 46 is adhered to the restrainingsheath 22 to fix the wire 20 and restraining sheath 22 together. Forexample, the restraining sheath 22 may be made out of a thermoplasticpolymer 50 like nylon, and the coiled portion 46 may be embedded withinthe thermoplastic polymer 50 like in FIG. 2 so that the thermoplasticpolymer 50 covers the coiled portion 46. The attachment of the coiledportion 46 to the restraining sheath 22 provides a stronger connectionbetween the restraining sheath 22 and the wire 20 compared to if therestraining sheath 22 and a wire 20 were only attached along thestraight portion 46 of the wire 20. At the transition between the coiledportion 46 and the straight portion 48, the wire 20 bends away from thehelical path of the coiled portion 46 and extends generally parallel tothe axis of the coiled portion 46. Preferably, the transition betweenthe coiled portion 46 and the straight portion 48 is located distal fromthe proximal end of the restraining sheath 22, although a part of thecoiled portion 46 could extend proximally from the proximal end of therestraining sheath 22. The straight portion 48 extends proximally fromthe restraining sheath 22, and as shown in FIG. 1, the straight portion48 extends across the space 44 between the restraining sheath 22 and thedeployment handle 14 and through the annular space 52 between thecovering sheath 26 and the inner catheter 24. Although the wire 20 mayhave various cross-sectional shapes, such as rectangular, thecross-section of the wire is preferably round.

In FIG. 2, the coiled portion 46 of the wire 20 may have a single coileddiameter and may extend only along the second portion 38 of therestraining sheath 22 where the second portion 38 is smaller in diameterthan the first portion 36 like FIG. 1. Alternatively, where therestraining sheath 22 has a single diameter along its length like inFIGS. 10 and 20, a single diameter coiled portion 46 like in FIGS. 2-3may extend along a part of the first portion 36 of the restrainingsheath 22. For example, the coiled portion 46 of the wire 20 couldextend along at least half the length of the stent 12 or along theentire length of the stent 12.

As shown in FIGS. 4-5, the coiled portion 46 of the wire 20 may have afirst section 54 with a coiled diameter that is larger than the coileddiameter of the second section 56. This arrangement may be useful withthe restraining sheath 22 of FIG. 1, where the first portion 36 hasinner and outer circumferences that are larger than the inner and outercircumferences of the second portion 38. Thus, the first section 54 ofthe coiled portion 46 may extend along a portion of the length of thestent 12, and the second section 56 may extend proximally from the stent12. As noted above, the first section 54 may extend along at least halfthe length of the stent 12 or along the entire length of the stent 12.

As shown in FIG. 6, multiple wires 20 may be adhered to the restrainingsheath 22. For example, it may be desirable to have at least two wires20 equally spaced around the inner catheter 24. Where the wires 20 havecoiled portions 46 adhered to the restraining sheath 22, the coiledportions 46 of the wires 20 may be spaced away from each other so thatthe coiled portions 46 fit within each other without interfering. Thecoiled portions 46 may also be oriented relative to each other so thatthe straight portions 48 are circumferentially spaced around the innercatheter 24. As also shown FIGS. 6-7, coiled wires 58 that do not extendproximally to the deployment handle 14 may also be spaced between thecoiled portions 46. In contrast to the wires 20 that have a coiledportion 46 and a straight portion 48, the coiled wires 58 may only becoiled without having a straight portion. The coiled wires 58 may alsoterminate where the wires 20 transition between the coiled portion 46and the straight portion 48 or distally from the transition. As shown inFIGS. 6-7, it may also be desirable for the coiled portions 46 andcoiled wires 58 to abut against each other along the restraining sheath22 to form a closed coil tube. As shown in FIG. 6, it may be possible inthis embodiment for the thermoplastic polymer 50 to only cover thecoiled portions 46 and the coiled wires 58 without being disposed alongthe inner surface of the coiled portions 46 and coiled wires 58. Thismay be desirable to reduce the profile of the restraining sheath 22. Alow friction liner 60, such as polytetrafluoroethylene (PTFE), may alsobe disposed along the inner surface of at least the first portion 36 ofthe restraining sheath 22 that extends along the stent 12. This may beuseful to reduce the friction between the restraining sheath 22 and thestent 12 to lower the force required to withdraw the restraining sheath22. For example, as shown in FIG. 6, the coiled portions 46 of the wires20 and the coiled wires 58 without a straight portion may extend onlyalong the second portion 38 of the restraining sheath 22 proximally fromthe stent 12. The liner 60 may then extend along the length of the stent12 and contact the outer surface of the stent 12. The thermoplasticpolymer 50 may cover the coiled portions 46 of the wires 20, the coiledwires 58 and the liner 60 to adhere all of the components together. Theembodiment of FIG. 6 may be used with a restraining sheath 22 like FIG.1 with a larger first portion 36 and smaller second portion 38, or mayalso be used with a restraining sheath 22 like FIGS. 10 and 20 where therestraining sheath 22 has a constant circumference along its length.

As shown in FIG. 7, it may also be desirable to provide the coveringsheath 26 with a coiled wire 62 embedded within a thermoplastic polymer64. This may be useful to strengthen the covering sheath 26 to minimizebuckling of the inner catheter 24 within the covering sheath 26.

Another embodiment of the delivery system 66 is shown in FIGS. 9-19. Forconciseness, features of the delivery system 10 that have been describedabove are not repeated below, since one of ordinary skill in the artwill understand that the principles described above could be used withdifferent types of delivered delivery systems including the deliverysystems 66, 90 of FIGS. 9-19 and 20-23. One advantage of the deliverysystems 66, 90 of FIGS. 9-19 and 20-23 is that they may be used with afamily of medical devices 12 that have different lengths whileminimizing the number of components that must be changed to accommodatedifferent length medical devices 12. For example, it may be possible touse the same restraining sheath 22, wires 20 and covering sheath 26 tomanufacture delivery systems 66, 90 that are suitable for differentlength stents 12. If a universal deployment handle 14 is used that canpull the wires 20 different lengths depending on the length of the stent12 that is used, such as a handle that winds up the wire 20, a commondeployment handle 14 may also be used. Thus, it may be possible toaccommodate an entire family of different length stents 12 by merelytrimming and end 68, 92 of the inner catheter 24 to accommodate longerlength stents 12.

For example, FIG. 9 shows the delivery system 66 with a covering sheath26 that extends over the proximal end of the restraining sheath 22 andextends proximally to the deployment handle 14 where it is fixed to thedeployment handle like in FIG. 1. Thus, the covering sheath 26 does notmove during deployment of the stent 12. The covering sheath 26preferably does not extend over any part of the restraining sheath 22that covers the stent 12. That is, since the covering sheath 26preferably does not move during delivery, the covering sheath 26 in thiscase should only extend over the portion of the restraining sheath 22located proximally from the stent 12 so that the covering sheath 26 doesnot interfere with expansion of the stent 12 when the restraining sheath22 is withdrawn. It is also preferable for the covering sheath 26 andthe restraining sheath 22 (illustrated in FIG. 10) to have inner andouter circumferences that are generally constant along the entire lengthof the covering sheath 26 and restraining sheath 22. This allows thelength of the restraining sheath 22 to be shorter in length relative toa restraining sheath 22 like FIG. 1, since the proximal end of therestraining sheath 22 can be closer to the proximal end of the stent 12.For example, it may be preferable for the restraining sheath 22 to beabout 1.5 times or less as long as the longest stent 12 in the family ofstents 12. However, the restraining sheath 22 must be at least as longas the longest stent 12 in the family and longer than the shortest stent12 in the family in order to use a common restraining sheath 22 in thedelivery system 66, 90. Thus, like FIG. 1, the length of the restrainingsheath 22 extends from the distal end of the stent 12 and terminatesdistally from the deployment handle 14 and prevents the stent 12 fromself-expanding prior to deployment.

As shown in FIGS. 10 and 12, the wire 20 is adhered to the restrainingsheath 22 and extends from the proximal end of the restraining sheath 22to the deployment handle 14. In order to use a common restraining sheath22, the longitudinal space between the restraining sheath 22 and thedeployment handle 14 must be at least as long as the longest stent 12 inthe family to allow enough space for the restraining sheath 22 to bewithdrawn from the stent 12. Thus, as shown in FIG. 12, the stent 12 isdeployed by pulling the wires 20 proximally to withdraw the restrainingsheath 22.

As shown FIGS. 12 and 14, the inner catheter 24 has a distal-facing end68 that either directly forms a stop surface 68 or supports a stopsurface 68, such as a metal or polymer ring. The stop surface 68 abutsthe proximal end of the stent 12 to prevent the stent 12 from movingproximally as the restraining sheath 22 is withdrawn. In order toaccommodate stents 12 with different lengths while using a commonrestraining sheath 22 and common wires 20 (illustrated in FIG. 17), thedistal-facing end 68 that forms or supports the stop surface 68 may betrimmed during manufacturing based on the length of each stent 12. Thus,the end 68 of the inner catheter 24 is trimmed so that when the proximalend of each stent 12 abuts the stop surface 68, the distal end of eachstent 12 in the family is positioned at the same general positionregardless of the length of each stent 12.

As shown in FIGS. 11, 14-16 and 18-19, this may be done by providing theinner catheter body 70 with a step 72 and providing a tube 74 thatslides over the distal portion of the inner catheter body 70 until theproximal end 76 of the tube 74 abuts the step 72. In this embodiment,the step 72 may be located at a common position so that the same innercatheter body 70 can be used for all delivery systems 66 in the family.The inner catheter 24 is thus trimmed to length by trimming the distalend 78 of the tube 74 to the appropriate length. As a result, after thetube 74 is trimmed and slid onto the inner catheter body 70, the distalend 78 of the tube 74 forms or supports the stop surface 68 for thestent 12. Preferably, the tube 74 is made from plastic, such aspolyether ether ketone (PEEK), and is preferably at least 5 mm long evenwhen trimmed for the longest stent 12 in the family.

As shown in FIGS. 11, 13 and 16, it may also be desirable for the wires20 to extend through corresponding passageways 80 in the inner catheter24 along a majority of the length between the deployment handle 14 andthe restraining sheath 22. This may be desirable to ensure that thewires 20 stay separated from each other and do not get entangled witheach other or interfere with each other when the restraining sheath 22is withdrawn. For example, the delivery system 66, 90 may curve aroundvarious bends in the anatomy, and without the wires 20 being restrainedand separated from each other, the wires 20 would tend to pull towardthe inner side of the curve. Although a restraining sheath 22 with asingle wire 20 may benefit from having the wire 20 extend through apassageway 80, 104 in the inner catheter 24, passageways 80, 104 for thewires 20 may be especially useful where two or more wires 20 are used tokeep the wires 20 separated from each other as explained. While a singlewire 20 may be used for the delivery system 10, 66, 90, in most casestwo or more wires 20 will be used to balance the withdrawing forcearound the circumference of the restraining sheath 22.

As shown in FIGS. 13 and 16, the passageways 80 may be closed. That is,each passageway 80 fully encloses the circumference of each wire 20along a portion of the length between the restraining sheath 22 and thedeployment handle 14. In contrast, as described further below and shownFIGS. 22-23, the passageways 104 may also be open, such that at leastpart of the outer side of each wire 20 is uncovered by the passageway104. As shown in FIG. 10, each of the wires 20 may be unenclosed along afirst length 82 proximal from the restraining sheath 22. The firstunenclosed length 82 will typically be at least as long as the stent 12being delivered to allow the restraining sheath 22 to be fully withdrawnfrom the stent 12. Preferably, the first length 82 may be about 2 timesthe length of the stent 12 being delivered or less. The wires 20 arepreferably enclosed within corresponding passageways 80 along a secondlength 84 proximal from the first length 82. The second length 84 may bea majority of the length between the deployment handle 14 and therestraining sheath 22, or may be the entire length between thedeployment handle 14 and the first length 82.

As shown in FIGS. 11 and 15-16, the wires 20 may enter the passageways80 through distal openings 86 formed through the step 72 on the innercatheter 24. As shown in FIG. 11, the wires 20 may angle inward from theretention sheath 22 along the first length 82 to enter the passageways80. As shown in FIGS. 11 and 19, the proximal end 76 of the tube 74 maybe provided with recesses 88 to allow the wires 20 to extend through therecesses 88 to enter the passageways 80. The recesses 88 may be alignedwith the distal openings 86 of the passageways 80 by insertingpositioning mandrels through the distal openings 86 before the tube 74is slid onto the inner catheter body 70. Thus, as the tube 74 is slidonto the inner catheter body 70, the outwardly extending, exposedportion of each positioning mandrel will guide the recesses 88 to lineup the recesses 88 and the passageways 80. It may also be preferable tobond the tube 74 to the inner catheter body 70 at the proximal end 76 ofthe tube 74 and at the step 72 on the inner catheter body 70. This maybe done by applying adhesive to the proximal end 76 of the tube 74 andthe step 72 as the tube 74 is slid onto the inner catheter body 70. Thepositioning mandrels also may prevent the adhesive from entering thepassageways 80 during bonding. The closed passageways 80 of FIGS. 13 and16 may be formed in any suitable manner, but it may be preferred to makethe inner catheter body 70 by extruding the inner catheter body 70 andforming the passageways 80 and the guide wire lumen 32 during theextrusion process. The step 72 on the inner catheter body 70 may also beformed by various methods, but centerless grinding may be a preferredmethod. Where the step 72 is formed by centerless grinding, the step 72may have a slight taper as shown in FIG. 16, and the proximal end 76 ofthe tube 74 may be provided with a corresponding inward taper. Althoughvarious materials may be used for the inner catheter body 70, onepossible material is polyether ether ketone (PEEK).

Another embodiment of the delivery system 90 is shown in FIGS. 20-23.For conciseness, features of the delivery systems 10, 66 that have beendescribed above are not repeated below, since one of ordinary skill inthe art will recognize that principles described above could be usedwith different delivery systems including the delivery system 90 ofFIGS. 20-23. In this embodiment, the end 92 of the inner catheter 24which is trimmed to accommodate stents 12 of different lengths may beintegral with the length of the inner catheter 24 that forms the innercatheter body 94. For example, in FIG. 21, the very end 92 of the innercatheter body 94 could be the end 92 that supports or forms the stopsurface 92. Thus, the inner catheter body 94 itself may be trimmed tolength depending on the length of the stent 12 being loaded into thedelivery system 90. Although various materials may be used for the innercatheter body 94, the inner catheter body 94 may be made from polyetherether ketone (PEEK), since the trimmed end 92 may be durable enough toform the stop surface 92 without requiring a separate metal or polymerring for the stop surface 92. In this embodiment, the portion of theinner catheter 24 that extends through the stent 12 and is attached tothe atraumatic tip 96 may be a separate liner 98 that extends throughthe lumen of the inner catheter body 94 and extends distally past thestop surface 92 to the atraumatic tip 96. Preferably, the liner 98extends proximally to the deployment handle 14 and is fixed to the innercatheter body 94 at the deployment handle 14. Thus, in this arrangement,the liner 98 forms the guidewire lumen 32, and preferably a lubriciousliner 98 may be used, such as polytetrafluoroethylene (PTFE). Althoughthe liner 98 may be bonded along the length of the inner catheter body94, the liner 98 may also float unattached within the lumen of the innercatheter body 94 and may be attached to the inner catheter body 94 atthe deployment handle 14.

One advantage of using a separate liner 98 attached to the atraumatictip 96 is that the tip 96 may be located closer to the proximal end ofthe stent 12 without needing to leave extra space at the distal end asis conventionally done during manufacturing when gluing the tip 96 ontothe inner catheter 24. For example, in this arrangement, the tip 96 maybe glued to the distal end of the liner 98 before the liner 98 ispositioned within the lumen of the inner catheter body 94. The liner 98may then be inserted into the central lumen of the inner catheter body94 after the stent 12 is loaded into the restraining sheath 22, and thestent 12 and restraining sheath 22 are positioned on the inner catheterbody 94. This allows the tip 96, which will form the leading end of thedelivery system 90, to be positioned next to the distal end of the stent12 after the tip 96 has been attached to the liner 98. As a result, themanufacturing assembler does not need to leave extra space to provideaccess for gluing and to prevent wet adhesive from contacting the stent12.

Like the delivery system 66 of FIGS. 10 and 12, the delivery system 90shown in FIGS. 20-21 may have a restraining sheath 22 with inner andouter circumferences that are generally constant along the entire lengthof the restraining sheath 22. As a result, the second portion of therestraining sheath 38 that extends proximally from the proximal end ofthe stent 12 may be shorter than the length of the stent 12 and may beshorter than the first portion 36 of the restraining sheath 22 whichextends along the length of the stent 12. Like FIG. 9, this allows thecovering sheath 26 shown in FIGS. 20-21 to also have inner and outercircumferences that are constant along the entire length of the coveringsheath 26.

As shown in FIGS. 21-22, the inner catheter 24 may be provided with afirst outer circumference 100 that extends proximally from the stopsurface 92 along a length at least as long as the length of the stent12. The inner catheter 24 may also have a second outer circumference 102extending proximally from the first outer circumference 100 along alength that is at least a majority of the length between the deploymenthandle 14 and the first outer circumference 100. Preferably, the secondouter circumference 102 extends along the entire length from thedeployment handle 14 to the first outer circumference 100. As shown, thesecond outer circumference 102 may be larger than the first outercircumference 100. The first outer circumference 100 is sized to besmaller than the inner circumference of the restraining sheath 22 sothat the restraining sheath 22 can slide proximally over the first outercircumference 100 of the inner catheter 24. The second outercircumference 102 may be sized larger than the inner circumference ofthe restraining sheath 22 since the restraining sheath 22 only needs tobe withdrawn a sufficient distance to release the stent 12 and istypically not withdrawn all the way proximally to the deployment handle14.

An advantage of increasing the size of the second outer circumference102 is that the clearance between the second outer circumference 102 andthe covering sheath 26 can be reduced. For example, the clearance perside between the second outer circumference 102 and the innercircumference of the covering sheath 26 may be about 0.0005″ or less. Byincreasing the size of the second outer circumference 102, the strengthof the inner catheter 24 may be increased, both by the increased size ofthe second outer circumference 102 and by the covering sheath 26reinforcing the inner catheter 24. Thus, the inner catheter 24 may beless likely to buckle and snake within the covering sheath 26 whencompressive force is applied to the inner catheter 24 during deploymentof the stent 12. In addition, because the covering sheath 26 does notmove relative to the inner catheter 24 during deployment, the clearancebetween the second outer circumference 102 and the covering sheath 26may be less than what would typically be needed to allow low frictionsliding between components. For example, in a conventional deliverysystem, the restraining sheath extends proximally all the way to thedeployment handle and slides along the entire length of the innercatheter during deployment. In that arrangement, sufficient clearance isrequired to allow low friction sliding between the restraining sheathand the inner catheter. Likewise, the clearance between the second outercircumference 102 and the inner circumference of the covering sheath 26may be less than the clearance between the outer circumference of therestraining sheath 22 and the inner circumference of the covering sheath24.

As shown in FIGS. 22-23, the passageways 104 extending through the innercatheter 24 for the wires 20 may be open as contrasted with the closedpassageways 80 of FIGS. 11 and 13. In other words, the wires 20 mayslide through passageways 104 that surround the inner circumference ofeach wire 20 while the outer circumference of each wire 20 is uncoveredby the passageway 104. As shown in FIG. 22, the distal opening 86 ofeach passageway 104 may be formed through the step 106 where the secondouter circumference 102 of the inner catheter 24 starts. As shown inFIGS. 20-21, the wires 20 may be unenclosed along the first outercircumference 100 of the inner catheter 24 from the proximal end of therestraining sheath 22. The unenclosed length is preferably at least aslong as the length of the stent 12 to allow the restraining sheath 22 tofully withdraw from the stent 22 without interfering with thepassageways 104. However, like FIG. 10, the unenclosed length ispreferably no more than about 2 times as long as the stent 12.Preferably, the wires 20 extend substantially straight from therestraining sheath 22 to the distal openings 86 of the passageways 104.Each of the wires 20 extends through a corresponding open passageway 104along a majority of the length from the deployment handle 14 to therestraining sheath 22. The wires 20 may also extend along the secondouter circumference 102 through passageways 104 the entire lengthbetween the deployment handle 14 and the first outer circumference 100.The passageways 104 may be formed in the second outer circumference 102in any suitable manner including extruding the passageways 104 duringforming of the inner catheter 24 or grinding the passageways 104 intothe second outer circumference 102. Although the passageways 104 inFIGS. 20-23 are open, the clearance between the inner catheter 24 andthe covering sheath 26 may be sized to prevent the wires 20 from comingout of the passageways 104 as shown in FIG. 23. For example, if thedelivery system 90 has at least two wires 20 equally spaced around theinner catheter 24, at least one third of the depth of each wire 20 maybe disposed within each passageway 104 and the clearance per sidebetween the second outer circumference 102 and the inner circumferenceof the covering sheath 26 may be about one third or less of the depth ofeach wire 20.

While preferred embodiments of the invention have been described, itshould be understood that the invention is not so limited, andmodifications may be made without departing from the invention. Thescope of the invention is defined by the appended claims, and alldevices that come within the meaning of the claims, either literally orby equivalence, are intended to be embraced therein. Furthermore, theadvantages described above are not necessarily the only advantages ofthe invention, and it is not necessarily expected that all of thedescribed advantages will be achieved with every embodiment of theinvention.

We claim:
 1. A self-expanding medical device delivery system,comprising: a self-expanding medical device comprising a distal end, aproximal end and a length therebetween; an inner catheter extendingproximally from said medical device to a deployment handle, said innercatheter comprising a stop surface adjacent said proximal end of saidmedical device and adapted to prevent said medical device from movingproximally during deployment of said medical device; a restrainingsheath comprising a first portion extending over said medical device andadapted to prevent said medical device from self-expanding prior todeployment of said medical device and a second portion extendingproximally of said medical device to a proximal end of said restrainingsheath, said second portion being at least as long as said length ofsaid medical device, said second portion having a constant outer profilethat is smaller than a constant outer profile of said first portion, andthe proximal end of said restraining sheath terminating distally fromsaid deployment handle; a wire adhered to the second portion of saidrestraining sheath and extending proximally from said restraining sheathto said deployment handle; and a covering sheath extending from saidrestraining sheath to said deployment handle, said covering sheathextending over and disposed radially outward from an outer surface of atleast said proximal end of said restraining sheath; wherein said medicaldevice is deployed by pulling said wire proximally to withdraw saidrestraining sheath proximally away from said medical device, and whereina longitudinal space inside said covering sheath is formed to receivesaid movable restraining sheath withdrawn proximally away from saidmedical device.
 2. The self-expanding medical device delivery systemaccording to claim 1, wherein said medical device is a stent.
 3. Theself-expanding medical device delivery system according to claim 1,wherein said inner catheter comprises a guidewire lumen extending from adistal end of said inner catheter to said deployment handle.
 4. Theself-expanding medical device delivery system according to claim 1,wherein said medical device is deployed by said deployment handlewinding up the wire, thereby pulling said wire proximally to withdrawsaid restraining sheath proximally away from said medical device.
 5. Theself-expanding medical device delivery system according to claim 1,further comprising a low friction liner adhered to said restrainingsheath and extending along said length of said medical device andcontacting an outer surface of said medical device, wherein saidrestraining sheath comprises a thermoplastic polymer covering said wireand said liner.
 6. The self-expanding medical device delivery systemaccording to claim 1, wherein said restraining sheath further comprisesa tapered portion between said first portion and said second portion. 7.The self-expanding medical device delivery system according to claim 1,wherein said covering sheath is fixed to said deployment handle and doesnot move during deployment of said medical device, said covering sheathextending over only a portion of said restraining sheath disposedproximally from said medical device.
 8. The self-expanding medicaldevice delivery system according to claim 7, wherein said coveringsheath comprises an inner circumference and an outer circumference thatare both generally constant along an entire length of said coveringsheath.
 9. The self-expanding medical device delivery system accordingto claim 8, wherein a distal end of said covering sheath comprises anatraumatic taper and a close fitting inner diameter around saidrestraining sheath that presents a smooth transition between saidrestraining sheath and said covering sheath.
 10. A self-expandingmedical device delivery system, comprising: a self-expanding medicaldevice comprising a distal end, a proximal end and a lengththerebetween; an inner catheter extending proximally from said medicaldevice to a deployment handle, said inner catheter comprising a stopsurface adjacent said proximal end of said medical device and adapted toprevent said medical device from moving proximally during deployment ofsaid medical device; a restraining sheath comprising a first portionextending over said medical device and adapted to prevent said medicaldevice from self-expanding prior to deployment of said medical deviceand a second portion extending proximally of said medical device to aproximal end of said restraining sheath, said second portion having aconstant outer profile that is smaller than a constant outer profile ofsaid first portion, and the proximal end of said restraining sheathterminating distally from said deployment handle; and at least one wireadhered to the second portion of said restraining sheath and extendingproximally from said restraining sheath to said deployment handle;wherein said medical device is deployed by pulling said at least onewire proximally to withdraw said restraining sheath proximally away fromsaid medical device; and wherein said restraining sheath comprises athermoplastic polymer, and a coil is embedded within the thermoplasticpolymer and extends along at least a portion of said length of saidmedical device.
 11. The self-expanding medical device delivery systemaccording to claim 10, further comprising a low friction liner disposedalong an inner surface of said restraining sheath and extending alongsaid length of said medical device and contacting an outer surface ofsaid medical device.
 12. The self-expanding medical device deliverysystem according to claim 10, wherein said stop surface is a metal orpolymer ring bonded to said inner catheter.
 13. The self-expandingmedical device delivery system according to claim 10, wherein saidmedical device is deployed by said deployment handle winding up said atleast one wire, thereby pulling said at least one wire proximally towithdraw said restraining sheath proximally away from said medicaldevice.
 14. The self-expanding medical device delivery system accordingto claim 10, wherein said restraining sheath further comprises a taperedportion between said first portion and said second portion.
 15. Theself-expanding medical device delivery system according to claim 10,wherein said medical device is a stent.
 16. A self-expanding medicaldevice delivery system, comprising: a self-expanding medical devicecomprising a distal end, a proximal end and a length therebetween; aninner catheter extending proximally from said medical device to adeployment handle, said inner catheter comprising a stop surfaceadjacent said proximal end of said medical device and adapted to preventsaid medical device from moving proximally during deployment of saidmedical device; a restraining sheath comprising a first portionextending over said medical device and adapted to prevent said medicaldevice from self-expanding prior to deployment of said medical deviceand a second portion extending proximally of said medical device to aproximal end of said restraining sheath, said second portion having aconstant outer profile that is smaller than a constant outer profile ofsaid first portion, and the proximal end of said restraining sheathterminating distally from said deployment handle; at least one wireadhered to the second portion of said restraining sheath and extendingproximally from said restraining sheath to said deployment handle; and acovering sheath extending from said restraining sheath to saiddeployment handle and fixed to said deployment handle, said coveringsheath extending over and disposed radially outward from an outersurface of at least said proximal end of said restraining sheath, adistal end of said covering sheath provided with an inner diameter thatclosely fits onto an outer diameter of said proximal end of saidrestraining sheath, and the distal end of said covering sheath includingan atraumatic tapered end that provides a smooth transition between saidrestraining sheath and said covering sheath; wherein said medical deviceis deployed by pulling said at least one wire proximally to withdrawsaid restraining sheath proximally away from said medical device, andwherein a longitudinal space inside said covering sheath is formed toreceive said movable restraining sheath withdrawn proximally away fromsaid medical device.
 17. The self-expanding medical device deliverysystem according to claim 16, wherein said covering sheath comprises athermoplastic polymer, and a coil is embedded within the thermoplasticpolymer.
 18. The self-expanding medical device delivery system accordingto claim 16, wherein said covering sheath comprises a first portion anda second portion extending proximally of said first portion, said secondportion of said covering sheath having an outer profile that is smallerthan an outer profile of said first portion of said covering sheath. 19.The self-expanding medical device delivery system according to claim 16,wherein said deployment handle includes a flushing port in fluidcommunication with an annular space between said covering sheath andsaid inner catheter and between said restraining sheath and said innercatheter.
 20. The self-expanding medical device delivery systemaccording to claim 16, wherein said medical device is deployed by saiddeployment handle winding up said at least one wire, thereby pullingsaid at least one wire proximally to withdraw said restraining sheathproximally away from said medical device.